ALLOMATRIX® Injectable Putty
146617-1
The following languages are included in this packet:
English (en)
For additional information and translations please contact the manufacturer or local distributor.
M
Wright Medical Technology, Inc.
5677 Airline Rd.
Arlington, TN 38002
U.S.A
June 2011
Printed in U.S.A.
Attention Operating Surgeon
IMPORTANT MEDICAL INFORMATION
ALLOMATRIX® Injectable Putty
(146617-1)
OUTLINE:
I.
A.
B.
C.
D.
E.
F.
G.
H.
GENERAL PRODUCT INFORMATION
DONOR SELECTION
SEROLOGICAL TESTING
ADVERSE EFFECTS
PRECAUTIONS
TRACEABILITY
HANDLING & USE
STORAGE CONDITIONS
LIMITED WARRANTY & LIMITATION OF LIABILITY
II. SPECIFIC PRODUCT INFORMATION
A.
ALLOMATRIX® INJECTABLE PUTTY
I. GENERAL PRODUCT DESCRIPTION
A. DONOR SELECTION
All tissue used in Wright Medical Technology’s (WMT) ALLOMATRIX® Injectable Putty
is recovered by U. S. tissue banks. A completed donor chart for the enclosed product
including but not limited to: serology results, recovery culture results, medical and social
history evaluation and serodilution calculation that was conducted by or contract tested by
and for the tissue bank, has been reviewed and approved for transplantation by the tissue
bank’s medical director. Donor screening and testing is performed in accordance with
American Association of Tissue Banks (AATB) standards and U.S. Food and Drug
Administration (FDA) regulations. All processing documentation has been reviewed and
approved by the tissue bank’s Quality Assurance department.
Each lot of product is manufactured using tissue from a single donor. There is no pooling of
donor tissue.
B. SEROLOGICAL TESTING
A donor serum sample was tested non-reactive using FDA licensed screening tests for
antibodies to human immunodeficiency virus type 1 and type 2 (anti-HIV 1 and anti-HIV 2),
hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), antibodies to the
hepatitis C virus (anti-HCV), and the human T-lymphotrophic virus type I antibody (antiHTLV I). The serum tested negative for syphilis using a FDA licensed confirmatory test.
The donor also tested negative for HIV using Polymerase Chain Reaction (PCR) technology
or an FDA-licensed NAT test.
Communicable disease testing was performed by a laboratory certified to perform such
testing on human specimens under the Clinical Laboratory Improvement Amendments of
1988 (42 U.S.C. 263a) and 42 CFR Part 493; or that has met equivalent requirements as
determined by the Centers for Medicare and Medicaid Services in accordance with those
provisions.
Additionally, the product meets all applicable serological testing requirements of the country
in which it is distributed.
C. ADVERSE EFFECTS
Possible adverse effects include but are not limited to:
• Wound complications including hematoma, site drainage, bone fracture, infection, and
other complications that are possible with any surgery
• Fracture or extrusion of the product with or without generation of particulate debris
• Deformity of the bone at the site
• Incomplete or lack of osseous ingrowth into bone void, as is possible with any bone graft
substitute
In the event of a severe adverse reaction to the product, a second surgery may be
required to remove any remaining product.
D. PRECAUTIONS
As with any surgical procedure, care should be exercised in treating individuals with
preexisting conditions that may affect the success of the surgical procedure. This includes
individuals with bleeding disorders of any etiology, long-term steroidal therapy,
immunosuppressive therapy, or high dosage radiation therapy.
Use ALLOMATRIX® Injectable Putty as supplied and according to the Handling and Use
information provided.
ALLOMATRIX® Injectable Putty is sterile during the stated shelf life as long as the
package is not opened and/or damaged.
As with any biological product, the tissue in WMT’s ALLOMATRIX® Injectable Putty has
the potential to transmit infectious agents. Processing treatments, donor screening, and
laboratory testing follow strict specifications that are used to reduce the risk of transmitting
infectious disease. Additionally, testing to evaluate the viral inactivation potential of the
processing methods was conducted. The Demineralized Bone Matrix (DBM) processing
methods were determined to provide significant viral inactivation potential for a wide range
of potential viruses. The Cancellous Bone Matrix/Chips (CBM) processing methods were
determined to provide some viral inactivation potential for a wide range of potential viruses.
In comparison, the CBM processing methods provided less viral inactivation potential than
the DBM processing methods; therefore, the risk for disease transmission from the CBM
component is greater than the DBM component. However, the risk of disease transmission
for these components remains low due to the multiple safeguards employed, i.e. donor
selection, laboratory testing, and material processing.
As with any surgical procedure, care should be exercised in treating individuals with
preexisting conditions that may affect the success of the surgical procedure. This includes
individuals with bleeding disorders of any etiology, long-term steroidal therapy, or
immunosuppressive therapy or high dose radiation therapy.
Trace amounts of alcohol and/or hydrogen peroxide, Polymyxin B sulfate, Bacitracin, and
Allowash® solution (contains detergents, such as polyoxyethylene-r-lauryl ether,
octylphenolethyleneoxide, and poly(ethylene glycol)-p-nonyl-phenyl-ether), may be present
and caution should be exercised if the recipient is allergic to these antibiotics.
This device has not been evaluated for safety and compatibility in the MR environment.
This device has not been tested for heating or migration in the MR environment.
WARNING: Do not use this device if the glass vial is cracked or broken.
E. TRACEABILITY
An implant tracking card has been included with the product and should be completed at the
time of surgery and returned to Wright Medical Technology, Inc. Record the name and
address of the medical facility, implant information (using the peel off stickers) and
comments regarding the use of the implant on the tracking card. The completed form should
be returned to Wright Medical Technology, Inc. Copies should be retained by the medical
facility in the patient medical record for tracking tissue post-transplantation.
F. HANDLING & USE
WMT’s ALLOMATRIX® Injectable Putty is supplied Electron Beam irradiated, sterile, and
should be considered sterile unless the inner packaging has been opened or damaged. Once
the inner packaging has been opened, this product should be used, if appropriate, or
otherwise discarded. The lyophilized DBM is aseptically processed by the tissue supplier.
This product should not be resterilized. This product is for single patient use and should not
be reused. Devices labeled for single-use only should never be reused. Reuse of these
devices may potentially result in serious patient harm. Examples of hazards related to the
reuse of these devices include, but are not limited to: significant degradation in device
performance, cross-infection, and contamination. Report any adverse events to Wright
Medical Technology, Inc.
ALLOMATRIX® Injectable Putty is supplied in a kit that contains the components and
tools required to mix the components. Detailed mixing and handling instructions are
included on the Mixing Instructions Card.
G. STORAGE CONDITIONS:
It is the responsibility of the medical facility or physician to maintain this product according
to recommended storage conditions. Do not use if this product has not been stored
according to the following storage conditions. This product must be stored in dry conditions
between the temperatures of 15-30°C/59-86°F and be protected from sunlight.
H. LIMITED WARRANTY & LIMITATION OF LIABILITY
Supplier of the tissue represents and warrants that the DBM will conform to the company’s
specifications and comply with AATB standards and FDA standards, as such standards may
be amended from time to time, for donor screening and evaluation.
SUPPLIER OF THE TISSUE MAKES NO OTHER EXPRESS OR IMPLIED
WARRANTIES REGARDING THE DBM INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE. WITHOUT LIMITING THE FOREGOING, SUPPLIER OF THE TISSUE
MAKES NO REPRESENTATIONS OR WARRANTIES REGARDING THE FITNESS
OF THE DBM FOR COMBINATION WITH CALCIUM SULFATE OR ANY OTHER
APPLICATION AND MAKES NO REPRESENTATIONS OR WARRANTIES WITH
RESPECT TO THE DBM AS COMBINED WITH CALCIUM SULFATE OR ANY
OTHER SUBSTANCE, INCLUDING OSTEOSET® BONE GRAFT SUBSTITUTE,
ALLOMATRIX® PUTTY AND IGNITE®. SUPPLIER OF THE TISSUE HEREBY
ADVISES THE COMPANY AND ALL USERS OF PRODUCTS CONTAINING DBM
THAT THERE IS AN INHERENT RISK OF DISEASE TRANSMISSION IN THE USE
OF THE DBM FOR ANY PURPOSE, INCLUDING IN COMBINATION WITH
CALCIUM SULFATE.
Allowash® is a registered trademark of LifeNet.
II. SPECIFIC PRODUCT INFORMATION
A. ALLOMATRIX® Injectable Putty
DESCRIPTION
ALLOMATRIX® Injectable Putty is a combination of Human Demineralized Bone Matrix
(DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.
For information concerning osteoinductive potential of ALLOMATRIX® Injectable Putty,
please see the enclosed Certificate of Osteoinductivity Potential.
ALLOMATRIX® Injectable Putty comes in the form of a kit with a premeasured powder,
premeasured mixing solution, and the tools necessary to mix the components. After the
powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can
then be handled and placed in the appropriate bone voids. This product is supplied sterile for
single patient use.
INDICATIONS
ALLOMATRIX® Injectable Putty is indicated only for bony voids or gaps that are not
intrinsic to the stability of the bony structure. ALLOMATRIX® Injectable Putty is intended
for use as a bone grafting material to fill, augment or reconstruct periodontal or
oral/maxillofacial defects
CONTRAINDICATIONS
ALLOMATRIX® Injectable Putty is contraindicated where the device is intended as
structural support in load-bearing bone and in articulating surfaces. Conditions representing
relative contraindications include:
• Severe vascular or neurological disease
• Uncontrolled diabetes
• Severe degenerative bone disease
• Pregnancy
• Uncooperative patients who will not or cannot follow postoperative instructions,
including individuals who abuse drugs and/or alcohol
• Hypercalcemia
• Renal impairment
• Patients with a history of or active Pott’s disease
• Active or latent infection in or about the surgical site
HANDLING AND USE
ALLOMATRIX® Injectable Putty is supplied in a kit that contains the components and tools
required to mix the components. Detailed mixing and handling instructions are included on
the Mixing Instructions Card.
ALLOMATRIX® is a registered trademark of Wright Medical Technology, Inc.